[18F]F-FAPI PET/CT and LAparoscopy in STagIng advanced gastric Cancer: a multicenter prospective study (PLASTIC-3 study).
Lianne Triemstra, Sarah W J M Spruijt, Dennis Vriens...
https://pubmed.ncbi.nlm.nih.gov/41299326/Actively Recruiting
Led by Leiden University Medical Center · Updated on 2025-08-27
250
Participants Needed
10
Research Sites
52 weeks
Total Duration
Researchers are studying a new type of scan called FAPI-PETCT to see how well it detects metastases in patients with advanced gastric cancer. The study aims to find out if this scan can better identify cancer spread, leading to changes in treatment plans such as avoiding unnecessary surgeries or shifting to comfort-focused care. It also evaluates whether the scan causes less burden for patients compared to current methods. Participants will receive the standard care for gastric cancer and undergo one additional FAPI-PETCT scan, where a small amount of 18F-FAPI-74 is given intravenously about 60 minutes before a PETCT scan lasting around 20 minutes. The results from this scan will help doctors decide on further tests or surgery needed. The study monitors changes in diagnosis and treatment decisions based on the scan. During the study, participants will complete questionnaires taking about 4 hours total and spend approximately 2 hours for the extra scan. Researchers will measure outcomes such as changes in treatment intent, diagnostic work-up, scan accuracy, incidental findings, patient burden, quality of life, and safety over about one year. Follow-up includes quality of life assessments and cost evaluations at multiple time points after staging.
CONDITIONS
[18F]F-FAPI PET/CT and Laparoscopy in Staging Advanced Gastric Cancer
S
Sarah Spruijt, M.D.
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Leiden University Medical Center
Lead Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 1 to 2 weeks
Participants undergo [18F]-FAPI-74 administration followed by PET/CT scanning to detect gastric cancer metastases, followed by additional diagnostics including staging laparoscopy if necessary.
1 visit for PET/CT scanning and 1 additional diagnostic laparoscopy visit if indicated
Duration - Up to 12 months
Participants are monitored after diagnostic evaluation for changes in treatment intent, health-related quality of life, and impact of incidental findings.
Visits at 3, 6, 9, and 12 months after diagnostic evaluation
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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Lianne Triemstra, Sarah W J M Spruijt, Dennis Vriens...
https://pubmed.ncbi.nlm.nih.gov/41299326/Leiden University Medical Center
Lead Sponsor